BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 5933093 · Received September 7, 2016

    Report

    Report Number
    1820334-2016-00952
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 12, 2016
    Report Date
    June 29, 2017
    Manufacturer
    COOK INC
    Product Code
    MMX
    UDI-DI
    00827002518353
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K160593. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DIFFICULT CANNULATION OF THE CONTRALATERAL LIMB, REQUIRING CANNULATION FROM A SUPERIOR APPROACH WAS EXPERIENCED DURING THE PROCEDURE ON THE (B)(6) YEAR OLD FEMALE PATIENT. WHEN SNARING THE THRU AND THRU WIRE IN THE COMMON ILIAC ARTERY, THE WIRE HAD ADVANCED DOWN THE SIDE OF THE 14FR SHEATH THAT THE INDY SNARE HAD BEEN INTRODUCED THROUGH. AFTER SNARING THE WIRE HIGH AND THEN SUBSEQUENTLY REMOVING VIA THE 14FR SHEATH, RESISTANCE WAS FELT AND THE SNARE DETACHED FROM THE END OF ITS DELIVERY SYSTEM .THE SNARE WAS NOTED TO BE JUST INSIDE THE DISTAL END OF THE 14FR SHEATH. TO REMOVE THE DETACHED SNARE, A 5MM BALLOON WAS ADVANCED AND INFLATED AT THE DISTAL END OF THE SHEATH AND THEN THE 14FR SHEATH WAS REMOVED COMPLETELY AND THE SNARE WAS RETRIEVED. A 14FR SHEATH WAS THEN REINSERTED FOR HEMOSTASIS AND A SECOND INDY SNARE WAS OPENED AND USED WITHOUT ANY ISSUES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583979 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A 00827002518353

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention